Use of roller compaction and fines recycling process in the preparation of erlotinib hydrochloride tablets.

摘要: This study focuses on improving the manufacturing process for a generic immediate-release tablet containing erlotinib hydrochloride by adding fines recycling during roller compaction. Due to large fraction of small-sized API particles, starting powder mixture was inconsistently fed into compactor. Consequently, poorly flowing granules with high ratio were produced. A step was, therefore, added existing compaction minimize risks caused poor granule flow. laboratory scale compactor and simulator used prepare at various conditions. The effect dry granulation parameters size distribution, flow, properties, dissolution profile evaluated. batch after had markedly improved distribution flowability while maintaining acceptable tensile strength rapid profile. application commercial resulted in reliable performance batch-to-batch consistency, which further confirmed bioequivalence reference product. Understanding how properties are impacted may enable fine-tuning optimal product quality.